irb perspective: concept of the community-wide irb david c. clark, phd assistant dean for clinical...
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IRB Perspective:
Concept of theCommunity-Wide IRB
David C. Clark, PhD
Assistant Dean for Clinical Research
Medical College of Wisconsin
Outline
• Required elements• Staging approval -- a practical consideration• The role of community-wide IRBs
Element 7: Additional protections
• Value-neutral questions that are sensitive to community norms and expectations
• Public disclosure after completion to apprise community of results, including demographics
• Creation of an independent data monitoring committee (not members of research team – variety of experts)
Element 8: Refreshing consent
• IRB responsible for ensuring that procedures are in place to inform each subject (or LAR), at earliest opportunity, of subject’s inclusion, details of investigation, and full consent information…
• … and procedures exist to inform subject that he/she may discontinue participation at any time
• If LAR used and subject improves, must consent subject
• If subject dies before LAR consent obtained, investigator must inform LAR about study participation as soon as possible
Additional FDA requirements
• IRB must document that licensed physician -- member of or consulting to IRB (and not participating in clinical investigation) -- agrees that waiver is allowable, by recording this in minutes
Exclusions
Waiver explicitly excludes:• Pregnant women, fetuses, human in vitro fertilization
• Prisoners
• What if some pregnant women accidentally included?
Staging the IRB review
The concept of explicit “stages”• “Feasibility and planning” stage• “Community disclosure and consultation” stage• “Final implementation readiness” stage
• Approval granted for well-delineated stages, rather than for entire study plan
• Investigators and IRB work together to formulate mutually acceptable “staging” units and boundaries
Inter-Institutional Agreements
• Any FWA institution may defer IRB review to another FWA institution by means of a written Inter-Institutional Agreement
• IRB of records takes responsibility for IRB requirements based on information submitted (know your partner!)
• Deferring institutions still have responsibility for their investigators, their involvement, and implementation of study
Community-wide IRBs
• Several IRBs may develop a common Inter-Institutional Agreement, with supporting MOU and conventions memorialized as “policies,” to create a “community-wide IRB”
• Wisconsin IRB Consortium University of Wisconsin at Madison Medical College of Wisconsin (Milwaukee) Marshfield Clinic (40 centers in N, W and central WI) Gundersen Lutheran Health System (La Crosse) Aurora Health Care (Milwaukee)
Role of community-wide IRBs
• Common Inter-Institution Agreements, policies and procedures for “network” studies facilitate multi-site reviews
• Consensual decision about “lead institution”• Subsidiary sites may defer review; conduct
a facilitated review; or conduct a full committee review
• Network orchestrates sequence and timing of reviews
Advantages of community-wide IRBs
• Each participating institution chooses its own preferred level of review, study by study
• Potential: for single IRB review with built-in procedures for
considering “local context” for full-information continuing reviews to choreograph consent form language across
multiple institutional IRBs
Disadvantages of community IRB review
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are needed to see this picture.
What is a successful community consultation?
• Type of consultation (community meeting, focus group, survey)?
• Number of consultations?• Number of persons consulted?
• (Limited time, staffing, and budget -- how much “respect for persons” can we afford?)
What is a successful community consultation?
• Community support ratio (51%)?• Sampling strategies (representativeness)?• Indication from community that there was
enough consultation?